Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3: The Truscope series patient monitors (Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI). The arrhythmia detection, ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

Truscope II and MINI: Truescope Series Patient Monitor (Truscope II and MINI) is intended to be used for monitoring. displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. Truescope Series Patient Monitor (Truscope II and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide

Truscope Classic: Truescope Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2). Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.

Device Description

The proposed device Truscope Patient Monitor is change from the Paitent Monitor manufactured by Guangdong Biolight Meditech Co., Ltd, all models included in this submission has exactly same design, materials, and manufacture process with their original model, only different is the model name and device name.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Truscope Patient Monitors based on the provided text:

Preamble: The provided document is a 510(k) summary for a patient monitor. For this type of device, the "study that proves the device meets the acceptance criteria" refers to non-clinical bench tests and adherence to recognized standards, rather than clinical trials with human subjects for novel AI algorithms. The acceptance criteria themselves are the performance requirements set by these standards. The device is a "Truscope Patient Monitor," which includes various models (Truscope Elite A8, A6, A5, A3, Truscope II, Truscope MINI, and Truscope Classic). The submission emphasizes that these models have the "exactly same design, materials, and manufacture process" as their previously cleared predicate devices, differing only in model/device name. Therefore, much of the "proof" revolves around demonstrating that these new models maintain the performance established by their predicates.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) for patient monitors, the acceptance criteria are generally established by recognized consensus standards. The document states that "Bench tests were conducted to verify that the proposed device met all design specifications" and "the test results demonstrated that the proposed device complies with the following standards." The reported device performance is implicitly that it complies with these standards and is Substantially Equivalent (SE) to the predicate devices.

Acceptance Criteria (Standard / Parameter)	Reported Device Performance
General Safety	Compliance with IEC 60601-1 (including Amendment 1, 1991-11, Amendment 2, 1995)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007
Cardiac Monitors, Heart Rate Meters, and Alarms	Compliance with AAMI EC13:2002
Cardiac Rhythm and ST-Segment Measurement Algorithms (Testing & Reporting)	Compliance with AAMI EC57:1998/(R) 2008
Manual, Electronic, or Automated Sphygmomanometers (NIBP)	Compliance with AAMI SP10:2002/ A1:2003 (R) 2008
Pulse Oximeter Equipment (SpO2)	Compliance with ISO 9919:2005
Overall Performance	Met all design specifications; Substantially Equivalent (SE) to predicate devices (K120193, K102040, K100046)
Design, Materials, Manufacturing Process	Exactly same as original predicate models

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "bench tests" to verify compliance with design specifications and standards.

Sample Size for Test Set: Not explicitly stated as a number of measurement points or patient cases. For a medical device like a patient monitor, "sample size" in this context would likely refer to the quantity of devices or components tested, and the range of input signals (e.g., simulated ECG waveforms, blood pressure values) applied during testing for each parameter. The document does not provide these specifics.
Data Provenance: Not specified. As the manufacturer is Guangdong Biolight Meditech Co., Ltd. (China), it is highly probable that the non-clinical bench testing took place in China. The nature of bench testing implies it is controlled, simulated data rather than patient data, making it neither retrospective nor prospective in the typical clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or provided for this type of submission. Bench tests for patient monitors typically rely on calibrated reference equipment and standardized test signals to establish "ground truth" for electrical, mechanical, and physiological parameter measurement accuracy, rather than expert human interpretation of complex data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or provided. Adjudication methods are typically used when human interpretation of complex data (e.g., images for a diagnostic AI) is involved in establishing ground truth. For technical performance testing of a patient monitor based on international standards, calibrated instruments serve as the reference.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a patient monitor, not an AI-powered diagnostic tool, and the submission is a 510(k) for substantial equivalence based on technical performance to predicate devices and adherence to standards, not a comparative effectiveness study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable in the context of advanced AI algorithms. While the device contains algorithms for ECG analysis (arrhythmia, ST segment), SpO2, NIBP, etc., these are integrated functionalities of a patient monitor, and their "standalone" performance is assessed through compliance with the relevant IEC/AAMI standards for those parameters (e.g., AAMI EC57 for ECG algorithms), which the document states has been met via bench testing. The term "standalone" in AI often implies a distinct algorithm separate from a human workflow, which isn't the primary focus here.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the bench tests conducted to verify the device's performance against the listed standards, the ground truth would be established by:

Calibrated reference equipment: For electrical safety, EMC.
Traceable test signals/simulators: For physiological parameters like ECG waveforms (known heart rate, arrhythmia types, ST deviation), blood pressure pressures, SpO2 saturation levels, temperature, and gas concentrations. These simulators generate signals with known, precise values which the device is expected to measure accurately.

8. The sample size for the training set

This information is not applicable or provided. The device is a patient monitor, not a machine learning model developed with a training set of data in the contemporary AI sense. Its algorithms are based on established signal processing principles and are validated against industry standards.

9. How the ground truth for the training set was established

This information is not applicable or provided. As mentioned above, there is no "training set" in the context of developing a machine learning model. The algorithms embedded in the patient monitor (e.g., for arrhythmia detection) are based on pre-defined criteria and validated against standardized test signals.

Summary

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Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

1. Date of Prepared: May. 15, 2013
Sponsor 2.

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Mr. Tianbao Li, Chief Engineer T: +86-756-3399963 F:+86-756-3399989 E:li_tb@blt.com.cn

1. Submission Correspondent
  Diana Hong & Tarzan. Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.

Proposed Device Name: Truscope Patient Monitors

Device Common Name: Patient Monitors

Proposed Device Model: Truscope Elite A8, Truscope Elite A6, Truscope Elite A5, Truscope Elite A3, Truscope Classic, Truscope II, and Truscope MINI;

Classification:

Regulation No.	Classification Name.	Product Code	Device Class
Main Code
21 CFR 870.1025	Arrhythmia detector and alarm (including ST-segment measurement and alarm)	DSI	Class II
Subsequent Product Codes
21 CFR 870.1025	Detector and Alarm, Arrhythmia	DSI	Class II
21 CFR 870.1025	Monitor, ST Segment with Alarm	MLD	Class II
21 CFR 870.2300	Cardiac monitor (including cardiotachometer and rate alarm)	DRT	Class II
21 CFR 870.1130	Non-invasive blood pressure measurement system	DXN	Class II
21 CFR 870.1110	Blood pressure computer	DSK	Class II
21 CFR 880.2910	Clinical Electronic Thermometers - Temperature Monitor with Probe	FLL	Class II
21 CFR 870.2700	Oximeter, Pulse	DQA	Class II
21 CFR 868.1400	Carbon Dioxide Gas Analyzer	CCK	Class II
21 CFR 868.1500	Enflurane gas analyzer	CBQ	Class II
21 CFR 868.1620	Halothane gas analyzer	CBS	Class II
21 CFR 868.1700	Nitrous Oxide gas analyzer	CBR	Class II
21 CFR 868.1720	Oxygen gas analyszer	CCL	Class II
21 CFR 882.1400	Electroencephalograph	GWQ	Class II
21 CFR 870.2770	Impedance plethysmograph	DSB	Class II

Table I-1 Classification of Truscope Patient Monitors

Intended Use Statement:

Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3

The Truscope series patient monitors (Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead

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selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI).

The arrhythmia detection, ST segment analysis only applied to a single adult patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

Truscope II and MINI

Truescope Series Patient Monitor (Truscope II and MINI) is intended to be used for monitoring. displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

Truescope Series Patient Monitor (Truscope II and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide

Truscope Classic

Truescope Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2). Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.

Predicate Device Identification 5.
510(k) Number: K120193

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Predicate Device Name: ANY VIEW PATIENT MONITORS ANY VIEW A6, ANY VIEW A8, ANYVIEW A3, ANY VIEW A5

Manufacturer: Guangdong Biolight Meditech Co., Ltd

510(k) Number: K102040

Predicate Device Name: PATIENT MONITOR ANY VIEW A6, ANY VIEW A8, M9500 Manufacturer: Guangdong Biolight Meditech Co., Ltd

510(k) Number: K100046

Predicate Device Name: M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000

Manufacturer: Guangdong Biolight Meditech Co., Ltd

Device Description 6.

The relationship between with the Truscope Patient Monitor and their original model matrix table list as following:

Truscope Patient Monitor Model	Original Patient Monitor Model
Truscope Elite A8	ANY VIEW A8 (K120193)
Truscope Elite A5	ANY VIEW A6 (K120193)
Truscope Elite A6	ANY VIEW A5 (K120193)
Truscope Elite A3	ANY VIEW A3 (K120193)
Truscope Classic	M9500 (K102040)
Truscope II	M69 (K100046)
Truscope MINI	M7000 (K100046)

7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
b) IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
AAMI EC13:2002, Cardiac monitors, heart rate meters, and alarms; c)
AAMI EC57:1998/(R) 2008, Testing and reporting performance results of cardiac rhythm and d) ST-segment measurement algorithms.
AAMI SP10:2002/ A1:2003 (R) 2008, Manual, electronic or automated sphygmomanometers; e)
() ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use;
1. Technological Characteristics Comparison There are any differences between proposed device and predicate except model name.
1. Substantially Equivalent Conclusion

The proposed device, Truscope Patient Monitors, are determined to be Substantially Equivalent (SE) to the predicate device, ANY VIEW PATIENT MONITORS (K120193), PATIENT MONITOR ( K102040) and M SEIRES PATIENT MONITOR (K100046) in respect of safety and effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 15, 2013

Guangdong Biolight Meditech Co., Ltd. c/o Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai. 200120 CH

Re: K131763

Trade/Device Name: Truscope Series Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Il (two) Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL. DQA, CCK, CBQ, CBR. CBS, CCL, CWQ. DSB Dated: June 9, 2013 Received: June 17, 2013

Dear Ms. Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

OwenPFAaris-S

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) Number:

Device Name:Truscope Patient Monitor/Model: Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3

Indications for Use:

Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3

The Truscope series patient monitors (Truscope Elite A6, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG (3-lead or 12-lead selectable), arthythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI).

The arrhythmia detection, ST segment analysis only applied to a single adult patient.

XPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Owen P.
Date:	2013.07.15 10:39:59
	-04'00'

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Project #:M0162012B

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510(k) Number:

Device Name: Truscope Patient Monitor/Model: Truscope II and MINI

Indications for Use:

Truscope II and MINI

Truescope Series Patient Monitor (Truscope II and MINI) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen
Paris
Date: 2013.07.15 10:40:28
-04'00'

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510(k) Number: Device Name:Truscope Patient Monitor/Model: Truscope Classic

Indications for Use:

Truscope Classic

Truescope Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen .
R. Faris: S
Date: 2013.07.15 10:40:49
-04'00'

Page 3 of 3

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.